ULTRAFILTER HECHINGEN

Additional Manufacturer Narrative

E1: INITIAL REPORTER ADDRESS: NO.(B)(6). THE DEVICE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Description of Event or Problem

IT WAS REPORTED THAT AN EXTERNAL FLUID LEAK WAS OBSERVED FROM THE U9000 ULTRAFILTER OF AN AK 96 MACHINE DURING SET UP. THE DEVICE WAS REPLACED TO CONTINUE SET UP. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.